Friday, April 26, 2024

Cigna to Offer Humira Rivals with $0 Copay at Specialty Pharmacy

(4/26, Patrick Wingrove and Amina Niasse, Reuters) ...Cigna plans to make close copies of AbbVie's blockbuster arthritis drug Humira available with no out-of-pocket payment to eligible patients in the U.S. using its specialty pharmacy beginning in June, the health insurer said on Thursday. Cigna said it will stock high- and low-concentration biosimilar versions of Humira from drugmakers including Boehringer Ingelheim, Teva and Alvotech at its Accredo pharmacy... Full

Vanda Comes Up Empty Handed As US Supreme Court Denies Hetlioz Appeal

(4/25, Dean Rudge, Generics Bulletin) ...Serial litigator Vanda Pharmaceuticals appears to have exhausted all options in its legal battle against Hetlioz (tasimelteon) abbreviated new drug application sponsors Teva and Apotex, after the US Supreme Court denied the originator's petition for a writ of certiorari review of a decisive patent-litigation loss for its landmark sleep disorder drug...At the end of 2022, Delaware district judge Colm Connolly found in favor of Teva and Apotex on their challenges to four Hetlioz method-of-treatment patents, which have expiry dates ranging from January 2033 to July 2035... Global Sub. Full

Evernorth's Accredo to Offer Humira Biosimilar at $0 Out-Of-Pocket

(4/25, Paige Minemyer, Fierce Healthcare) ...Evernorth's Accredo arm will make a Humira biosimilar available to patients with no out-of-pocket costs, the company announced Thursday...Most patients will be able to secure the biosimilar products for $0 out-of-pocket through the copay assistance programs offered at Quallent beginning in June, Evernorth said. Matt Perlberg, president of Evernorth Health Services' pharmacy and care delivery businesses, told Fierce Healthcare in an interview that biosimilars overall have significant promise to reduce costs for patients... Full

Biogen Chases Fresenius After Revealing EU Tocilizumab Nod

(4/26, David Wallace, Generics Bulletin) ...Ahead of the EMA's CHMP publishing its April meeting highlights, Biogen has revealed a positive opinion for its Tofidence biosimilar tocilizumab rival to RoActemra. However, Fresenius already has a version on the market...While Biogen did not disclose launch plans for Tofidence, it will not be first to the European market with a tocilizumab biosimilar. That honor went to Fresenius Kabi, which launched its Tyenne version – approved in both subcutaneous and intravenous formulations – towards the end of last year... Global Sub. Full

Sage Focuses On Successful Launch of Postpartum Depression Drug

(4/25, Beth Snyder Bulik, Endpoints News) ...Sage Therapeutics is doubling down on the "blockbuster potential" of its postpartum depression drug Zurzuvae, expanding professional promotions and taking steps toward a direct-to-consumer launch after a series of disappointments...Sage's share of Zurzuvae sales — it splits revenue with development partner Biogen — was $6.2 million in its first three months on the market, the company reported Thursday. So far, 700 prescriptions have been delivered to patients, with 1,200 written in total... Full

Sanofi Leans On COPD As 'Next Major Growth Pillar' for its Immunology Star Dupixent: CEO

(4/25, Fraiser Kansteiner, Fierce Pharma) ...Even as new Sanofi drugs like Beyfortus and Altuviiio come into their own, the French pharma's immunology powerhouse Dupixent shows no signs of slowing down. In fact, Sanofi is already gearing up for the antibody's potential debut in what CEO Paul Hudson dubbed the drug's "next major growth pillar." Sanofi is preparing to launch Dupixent in chronic obstructive pulmonary disease "as early as late June," Hudson said on an analyst call Thursday. The FDA is set to rule on Dupixent's merits in COPD on June 27... Full

Formycon Reports 83% Revenue Increase in 2023

(4/25, Skylar Jeremias, The Center For Biosimilars) ...Formycon, a Germany-based biosimilar manufacturer, shared that its revenues for 2023 were 83% higher than in 2022 (€45.5 million [$48.8 million]), reaching a total of €77.7 million ($81.2 million), according to its annual earnings report...The company attributed part of its success to more market launches for FYB201, also known as Cimerli (ranibizumab-eqrn), as well as progress in the development of FYB202, an ustekinumab biosimilar, and FYB203, a biosimilar for aflibercept, which both have applications under review with the FDA and European Medicines Agency... Full

AstraZeneca On Emerging Markets, GLP-1 Plans and Why it's Selective About Vaccines

(4/25, Ayisha Sharma, Endpoints News) ...AstraZeneca put the spotlight on its near-20% revenue growth during first-quarter earnings, driven in part by its success in emerging markets...Revenues beat analyst expectations: AstraZeneca's total Q1 sales jumped to $12.7 billion, besting analyst consensus of $11.8 billion. Besides strong demand in both the US and Europe, business "grew substantially in the emerging markets, and growth was especially pronounced outside of China," CEO Pascal Soriot said, according to an AlphaSense transcript... Full

Bristol Myers Outlines ‘About 12' Pipeline Cuts as it Executes Major Cutbacks

(4/25, Max Gelman, Endpoints News) ...As part of its sweeping $1.5 billion cost-cutting measure, Bristol Myers Squibb is culling "about 12" programs from its pipeline, CMO Samit Hirawat said Thursday morning. The programs will either be discontinued or externalized as Bristol Myers slashes costs company-wide in Chris Boerner's first major move as chief executive...With the pipeline changes, Bristol Myers is seeking to prioritize medicines with the highest potential return on investment, CFO David Elkins said... Full

Astellas Loses Bid to Block Myrbetriq Copies During Patent Suit

(4/25, Christopher Yasiejko, Bloomberg Law) ...A federal judge rejected Astellas Pharma Inc.'s requests to block Lupin's and Zydus' copies of the overactive-bladder treatment Myrbetriq during a patent-infringement suit, finding an injunction in a related appeal doesn't change the court's assessment that Astellas is unlikely to overcome invalidity arguments... Sub. Req'd

Global Generic Drugs Market to Reach $671.5B by 2030, Report Finds

(4/25, Sandra Levy, Drug Store News) ...The global economic update coincides with a rising demand for generic painkillers, reflecting the growing significance of generic drugs in the pharmaceutical market. Competition among key players is highlighted, with market share percentages and competitive market presence outlined for 2023. Despite promising opportunities, sustaining success in this market requires strategic approaches. Challenges such as pricing dynamics and accessibility persist, but recent market activity suggests ongoing developments in response to these challenges, per the report... Full

Novo Nordisk Lands Back in Sanders' Crosshairs, This Time Over Steep Costs of Ozempic and Wegovy

(4/25, Fraiser Kansteiner, Fierce Pharma) ...Just a few months after laying into CEOs from Bristol Myers Squibb, Merck & Co., and Johnson & Johnson about the high costs of their drugs, Sen. Bernie Sanders, I-Vermont, is taking Novo Nordisk to task for allegedly turning its blockbuster GLP-1s, Ozempic and Wegovy, into "luxury goods."..."As important as these drugs are, they will not do any good for the millions of patients who cannot afford them," Sanders wrote in this week's letter announcing a formal investigation into Novo's pricing strategies... Full

Mark Cuban Has a Simple Question for CVS's Drug Middleman: Why Don't You Publish Your Prices?

(4/26, Marty Schladen, Ohio Capital Journal) ...Businessman and TV personality Mark Cuban has a seemingly straightforward question for the huge drug middleman owned by CVS: If you're as transparent about drug pricing as you claim, why don't you publish prices on your website...A spokesman for CVS Caremark didn't respond directly to a question asking whether, through its negotiations, the company impacts the prices of branded drugs... Full

Wave of Amicus Briefs Back Drug Price Plan at Trial Court Stage

(4/26, Nyah Phengsitthy, Bloomberg Law) ...Former government officials, legal and economic scholars, and patient advocacy groups have become "friends of the court" in lawsuits by pharmaceutical giants and industry groups fighting the constitutionality of the Medicare Drug Price Negotiation Program. The plan, which is considered one of President Joe Biden's signature health initiatives under the Inflation Reduction Act, is expected to slash the costs of 10 Medicare Part D drugs beginning in 2026... Sub. Req'd

IRA is Already Negatively Impacting Access to Medicines in Part D

(4/25, Nicole Longo, PhRMA) ...Medicare Part D provides prescription drug coverage for our nation's seniors and Americans with disabilities. As a result of Part D, nearly 90% of Medicare beneficiaries have comprehensive drug coverage, amounting to more than 50 million beneficiaries in 2023, and year after year, seniors have reiterated their satisfaction with the program. Unfortunately, price setting measures like in the Inflation Reduction Act (IRA), coupled with structural changes to the program, have put much of what has worked for patients in Part D at risk... Full

LETTER: Drug Price Oversight Bill Would Have Unintended Consequences

(4/24, Rob Karr, Herald & Review) ...The uncertainty surrounding changes in drug pricing and regulations creates additional economic instability for small businesses. Fluctuations in healthcare costs and coverage options make it difficult for business owners to budget effectively and plan for the future, potentially stalling expansion efforts and undermining long-term sustainability. These impacts will hit businesses across all sectors, including pharmacies that are often relied on to fill the gaps in healthcare in communities across Illinois. This comes even as they continue to see their reimbursements cut for serving patients... Full

Review of Biosimilar Market – Pricing and Uptake

(4/25, Bob Pollock, Lachman Consultants) ...In an April 24, 2024 article in Matrix Global Advisors, Alex Brill and Christy Robinson provide an interesting commentary on the Current and Future State of U.S. Biosimilars. In the article, they address a number of issues regarding the current biosimilar market and the direction it is taking. They also describe the varied uptake of various approved biosimilar products in different therapeutic areas... Full

Prioritizing Lower-Priced Biosimilar Medications

(4/25, Danny Sanchez, Drug Store News) ...I believe how PBM companies respond to the growing biosimilars opportunity is another crucial test for our industry. Will PBMs stick with their old business model, which maximizes drug rebates at the expense of plan sponsors and their members, or will they embrace the value-driven approach that puts customers and patients first... Full

A Proven Model to Combat U.S. Drug Shortages

(4/25, Dan Liljenquist, Harvard Business Review) ...Drug shortages continue to plague the United States. In many ways, the problem is the result of deficiencies in the current pharma market. But a model for addressing this problem is showing that it isn't intractable. The company employing this model is Civica Rx, which was established in 2018 by health systems and philanthropies to address shortages of generic sterile injectable drug. This article discusses the elements of its model and its achievements... Full

Why Won't USTR Strengthen Medical Supply Chains with America's Allies?

(4/25, Douglas Petersen, PhRMA) ...If USTR genuinely intends to "advance supply chain resilience in trade negotiations" — as the agency's request for comments states — then USTR first must undertake trade negotiations. In so doing, USTR should enhance regulatory cooperation, prioritize intellectual property and eliminate barriers to trade in medicines, inputs and related goods. Despite USTR's misguided views, further enhancing the resilience of U.S. supply chains cannot be achieved absent an ambitious, pro-innovation trade agenda... Full

USTR Respects Fight for Medicine Access, Within WTO Rules

(4/25, Public Citizen) ...Today the U.S. Trade Representative released its annual Special 301 Report, which criticizes countries' intellectual property practices and establishes U.S. positions on global controversies such as patents and access to medicines, including "TRIPS flexibilities" under World Trade Organization rules. In a shift this year, USTR states its "policy of declining to call out countries for exercising TRIPS flexibilities, including with respect to compulsory licenses, in a manner consistent with TRIPS obligations."... Full

FDA Revises Guidance On Biosimilar Promotional Labels and Advertising

(4/25, Beth Snyder Bulik, Endpoints News) ...Following a recent move to ask Congress to eliminate the interchangeability designation for biosimilars, the FDA on Wednesday proposed updated guidance on the labeling and advertising of biologics and biosimilars. The new draft offers requirements around the content of promotional communications, and it follows the thinking around eliminating interchangeability in several places, changing up language and lumping biosimilars and interchangeable biosimilars together... Full

State Of Play: Does UK See Value In Generics and Biosimilars?

(4/25, Urte Fultinaviciute, Generics Bulletin) ...With 80% of medicines used by the UK's National Health Service being off-patent drugs, the UK is nevertheless in need of a new economic framework to save waning competition due to low prices, delegates to a Westminster Health Forum conference heard from a Sandoz executive...This was also recently voiced by the British Generic Manufacturers Association, with the organization saying that the UK risks being "deprioritized as a supply market" by off-patent drug suppliers unless urgent action is taken to provide targeted policy support for the sector... Global Sub. Full

Europe Falling Behind US and China in Pharma Innovation, Warns AstraZeneca Chief

(4/25, Ian Johnston, Financial Times) ...Europe is "falling behind" the US and China in life sciences innovation, the chief executive of AstraZeneca has said, warning that one of the continent's leading industries needs to spend more on research and pay staff better...Nicolai Tangen, chief executive of Norway's $1.6tn oil fund, said on Wednesday that Europeans were "less hard-working" than Americans, leading to US companies outpacing European rivals in innovation... Full

Experts Urge Action On Regulatory Science Collaboration In Korea

(4/25, Jung Won Shin, Pink Sheet) ...Experts discussed regulatory science issues at a recent forum in South Korea, including the responsibilities of sponsors and regulators as well as the need to strengthen collaborations and accelerate the development of innovative drugs and converged medical products... Sub. Req'd

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